Surgical tools for spinal facet therapy to alleviate pain and related methods

ABSTRACT

Methods and surgical tools for treating back pain use a spinal facet debridement tool with cautery and denuding action and minimally invasive protocol that can denude and cauterize soft tissue associated with a synovial capsule of the spinal facet joint.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/810,683, filed Jul. 28, 2015, which claims the benefit of andpriority to U.S. Provisional Patent Application Ser. No. 62/031,037filed Jul. 30, 2014, U.S. Provisional Patent Application Ser. No.62/043,537 filed Aug. 29, 2014, and U.S. Provisional Patent ApplicationSer. No. 62/135,791 filed Mar. 20, 2015, the contents of which arehereby incorporated by reference as if recited in full herein.

FIELD OF THE INVENTION

The present invention relates to spinal medical procedures.

BACKGROUND

The facet joint is unique in that it has innervations via a single nervesource. For many years, a process of facet joint rhizotomy (RFL) hasbeen utilized to provide temporary relief of spinal arthritis pain. RFLprocedures involve cryotherapy or radiofrequency techniques to eitherfreeze or burn the nerve. RFL is temporary because the nerve isdestroyed at a point between the dorsal root ganglion (the nerve cell'sbody) and the end plate receptors (pain stimulation points on the joint)and thus, like any peripheral nerve, the nerve gradually regenerates andthe pain eventually returns. Most RFL procedures last between 4 and 8months and must be repeated when the pain returns for the rest of thepatient's life for effective pain relief. Another option involves spinalfusion which is an expensive and relatively complex surgery with asuccess rate of only around 50% for spinal arthritis and few spinesurgeons would perform such a surgery for spinal arthritis. Spinalfusion involves inserting rods and screws into the spine to permanentlylock the joints.

Alternatively, upon proper training, a facet treatment (which can bedescribed as a debridement procedure) can be performed on a cervical,thoracic or lumbar facet joint of a human spine. During facetdebridement, the synovial capsule between facets is removed so as todenude the bone and denervate the joint (preventing reinnervation).

In the past, it is believed that only a few surgeons have been able tocarry out a facet debridement procedure. The procedure was carried outusing a plurality of separate instruments including a long wire handburr to denude tissue and a cauterization tool to cauterize remainingtissue. Cauterization may be needed to stop bleeding, to preventre-growth of removed tissue, and/or for other purposes. This often meansthat a surgeon must revisualize the operative site after changinginstruments and locate the area to be cauterized. This can be especiallyproblematic in laparoscopic procedures. Specifically, the surgeon mustremove the grinder or other mechanical cutting instrument from acannula, insert a cauterization instrument, and then cauterize theappropriate region.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Embodiments of the present invention provide relatively rapid, minimallyinvasive and cost effective treatments for long term, typicallypermanent, pain relief for spinal arthritis pain.

Some embodiments are directed to methods of minimally invasivelytreating a patient for back pain, including, for example spinal facetarthritis.

The method can be carried out as an outpatient procedure.

Embodiments of the invention provide surgical systems with a guidecannula having at least one exhaust port and a hand grip member that isattached to the guide cannula (integrally or releasably attached) toallow for a twist and push action of the guide cannula.

The target spinal facet joint can be a lumbar spinal facet joint and thecannula and debrider tool can extend out of the patient at an angle ofbetween about 10-40 degrees laterally, perpendicular to the targetspinal facet joint.

The target spinal facet joint can be a cervical or thoracic spinal facetjoint and the cannula and debrider tool can extend out of the patient atan angle of between about 0-10 degrees laterally, perpendicular to thetarget spinal facet joint.

Systems for the therapy can include an electrocautery generator thatoperates with a power curve having a maximum wattage of 50 Watts,typically about 40 Watts.

Embodiments of the invention are directed to methods of minimallyinvasively treating a patient for back pain. The methods include: (a)introducing a guide cannula into the patient so that a distal endresides proximate a target spinal facet joint; (b) attaching the guidecannula to an external stabilizer before, during or after theintroducing step; then (c) denuding and cauterizing soft tissue at thetarget spinal facet joint, serially or concurrently, using a tool with adenuding and cauterization head that extends through the guide cannula.The denuding is carried out by rotating the head of the tool to removean end plate receptor region comprising the synovial capsule of thespinal facet joint thereby treating back pain. The method also includes(d) suctioning fluid from the guide cannula and out of a vacuum port inthe stabilizer during the cauterizing to exhaust heat generated from thecauterizing.

The guide cannula can have a plurality of longitudinally spaced apartheat exhaust ports, the method further comprising aligning a selectedguide cannula heat exhaust port with the stabilizer vacuum port beforeor during the attaching step.

The attaching can be carried out to lockingly engage an external portionof the guide cannula at a desired user adjustable height to position adistal end of the guide cannula at the target spinal facet joint beforethe denuding and cauterizing is carried out.

The introducing step can be carried out by concurrently manuallyrotating and pushing the guide cannula inward toward the target spinalfacet joint over a dilation tube to position the distal end of the guidecannula proximate the target spinal facet joint before the denuding andcauterizing.

The method can include concurrently rotating and pushing the guidecannula inward toward the target spinal facet joint before attaching theguide cannula to the external stabilizer.

The concurrent rotating and pushing can be carried out using a hand gripattached to an external portion of the guide cannula.

The introducing step can be carried out by first inserting a k-wire orpin into the patient into bone at the target spinal facet joint, theninserting a dilation tube over the k-wire or pin into the patient, theninserting the guide cannula over the dilation tube. A hand grip can beattached to the guide cannula before, during or after the guide cannulais inserted over the dilation tube so that the dilation tube and k-wireor pin extend out of the hand grip above the guide cannula. Then a usercan concurrently rotating and pushing inward against the hand grip tocut through tissue adjacent the target spinal facet joint and therebyposition a distal end of the guide cannula at the target spinal facetjoint.

The introducing step can visually confirm the guide cannula is in adesired location by referring to visual guide marks on the k-wire or pinabove the hand grip.

The method can include, before the cauterizing and denuding, connectingthe tool to an electrosurgical generator with an RF source. Thecauterizing can be carried out using a power curve with a maximum outputwattage of 50 Watts, a maximum current of 1000 mA, and a maximum voltagein a range of 180V and 220 V.

The power curve for the electrosurgical generator can have a maximumoutput wattage of 40 Watts, a maximum current of 1000 mA, and a maximumvoltage in a range of 180 V and 220 V (optionally with an ohmic range of0-3000 ohms).

Yet other embodiments are directed to methods of minimally invasivelytreating a patient for back pain by denuding a target spinal facet jointusing a combination cautery and denuding tool. The denuding is carriedout by rotating a head of the tool at a rotational speed of between 10and 5000 rotations per minute to remove an end plate receptor regionwith the synovial capsule of the spinal facet joint thereby treatingback pain. The method can include cauterizing the target spinal facetjoint, serially or concurrently with the denuding, using the combinationcautery and denuding tool connected to an electrosurgical generatorhaving a power curve with a maximum output wattage of 40 Watts, amaximum current of 1000 mA, and a maximum voltage in a range of 180V and220 V. The method can include suctioning heat during at least thecauterizing to exhaust heat generated from the cauterizing.

Yet other embodiments are directed to surgical tools for spinal facetsurgical procedures for alleviating spinal pain. The surgical toolsinclude a guide cannula with a wall surrounding a cylindrical channel,the wall having a plurality of longitudinally spaced apart fluid portsextending therethrough. The surgical tools also include an externalstabilizer with a base configured to rest against skin of a patient. Thebase holds a tube that extends outward above the base and comprises atleast one vacuum port. The tube releasably engages the guide cannula.When assembled, the stabilizer at least one vacuum port is in fluidcommunication with at least one of the guide cannula fluid ports.

The tube that extends outward from the base can hold an arm that extendsperpendicularly outward from an axial direction of the tube about thevacuum port. The arm can releasably attach to a conduit which engages avacuum source.

The guide cannula fluid ports can be heat exhaust ports and/or canremain closed until selectively opened by a user.

The plurality of longitudinally spaced apart fluid ports can be between3-10.

The longitudinally spaced apart fluid ports can be in-line.

The arm of the tube held by the base that connects to a vacuum sourcecan have a length that is between 1 and 3 inches.

The surgical tools can include a hand grip member configured to attachto the guide cannula to thereby allow a user to concurrently rotate andpush against the guide cannula.

The hand grip member can have an open center channel extendingtherethrough with a circumferentially extending stop surface thatreleasably engages a proximal end of the guide cannula.

The hand grip member can include a longitudinally extending recess thatslidably engages a longitudinally extending protrusion on the guidecannula. The longitudinally extending guide protrusion can hold thelongitudinally spaced apart fluid ports.

The surgical tools can include a k-wire or guide pin that has visualmarkings thereon for allowing a user to determine a depth of a distalend of the guide cannula relative to the k-wire or guide pin when thek-wire or guide pin is in bone at a target spinal facet joint.

Yet other embodiments are directed to surgical tools that include anexternal stabilizer configured with a bottom surface that residesagainst skin of a patient. The stabilizer has an upwardly extending tubewith a through channel that is held by the base and the tube has a wallthat includes a vacuum port extending therethrough. The tube thatextends upwardly from the base can hold an arm that extendsperpendicularly outward from an axial direction of the tube about thevacuum port. The arm is adapted to attach to a vacuum source.

The surgical tool can be used in combination with a guide cannula. Theguide cannula can have a cylindrical wall that surrounds an openthrough-channel. The wall can include a plurality of longitudinallyspaced apart ports extending though the wall. The stabilizer can besized and configured to releasably hold the guide cannula while allowingthe guide cannula to align at least one of the guide cannula ports withthe stabilizer tube vacuum port. The bottom surface of the stabilizercan have a perimeter with a width that is between about 2-6 inches.

The surgical tool can be used in combination with a hand grip thatdetachably engages the guide cannula. The hand grip can have an opencenter channel that is concentric with the guide cannula channel.

Still other embodiments are directed to surgical tools for spinal facettherapies. The tools include a housing, an electric motor in thehousing, and a shaft held by the housing that rotates to turn a cauteryand denudement head at a low speed. The shaft has a head with a linearcautery element and first and second diametrically opposing tissuescraping members that face each other across the linear cautery element.The tools also include a connector that electrically connects thecautery and denudement head to a power source and a circuit in thehousing configured to carry out one or both of: (i) monitor wattagesupplied by the cautery source to inhibit or prevent operation ifwattage is above 50 Watts; and/or (ii) destroy or disengage one or morecomponents of the tool based on a defined triggering event to inhibitre-use.

Yet other embodiments are directed to spinal facet therapy systems. Thesystems include an electrosurgical generator having a definedoperational power curve with a maximum wattage of 60 Watts and a spinalfacet therapy tool with an elongate rotatable shaft. The shaft has adistal end with a cautery element. The tool is in communication with theelectrosurgical generator and is configured to automatically rotate atbetween about 10 rpm to about 5000 rpm to remove an end plate receptorregion with the synovial capsule of the spinal facet joint. Theelectrosurgical generator supplies power to the cautery element whilethe shaft rotates or is stationary. The system also includes a guidecannula with at least one fluid port extending through a longitudinallyextending wall thereof, the guide cannula configured to hold the toolshaft during an active treatment. The system also includes a stabilizerresiding against skin of a patient and holding the guide cannula thereinduring the active treatment. The stabilizer includes at least one vacuumport in fluid communication with the guide cannula at least one fluidport and a vacuum source to thereby suction heat from the guide cannulawhen the cautery element is cauterizing.

The tool can have an onboard electrical motor. The electrosurgicalgenerator can include a Field-Programmable Gate Array (FPGA)architecture for controlling output based on the defined power curve.

The electrosurgical generator can be held in a housing that also holds apower source for the motor.

The power curve can have a maximum output wattage of 50 Watts, a maximumcurrent of 1000 mA, and a maximum voltage in a range of 180V-220 V.

The power curve can have a maximum output wattage of 40 Watts, a maximumcurrent of 1000 mA, and a maximum voltage of 180V-220 V (optionally withan ohmic range some or all of 0-3000 ohms).

The spinal therapy system can include a hand grip member that can beconfigured to detachably couple to the guide cannula to thereby allow auser to concurrently rotate and push against the guide cannula to placethe guide cannula in a desired position prior to inserting the toolshaft into the guide cannula.

The hand grip member can have an open center channel extendingtherethrough with a circumferentially extending stop surface thatreleasably engages a proximal end of the guide cannula.

The hand grip member can include a longitudinally extending recess thatslidably engages a longitudinally extending protrusion on the guidecannula. The longitudinally extending guide cannula protrusion can holdthe longitudinally spaced apart fluid ports.

The spinal therapy system can include a k-wire or guide pin that hasvisual markings thereon for allowing a user to determine a depth of adistal end of the guide cannula relative to the k-wire or guide pin whenthe k-wire or guide pin is in bone at a target spinal facet joint.

The cautery element can be or comprise a linear cautery element thatextends straight across a distal face of the distal end of the shaft.The distal end of the shaft can also includes first and seconddiametrically opposing tissue scraping members that face each otheracross the linear cautery element.

It is noted that aspects of the invention described with respect to oneembodiment, may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail in the specification set forth below.

Other systems and/or methods according to embodiments of the inventionwill be or become apparent to one with skill in the art upon review ofthe following drawings and detailed description. It is intended that allsuch additional systems, methods, and/or devices be included within thisdescription, be within the scope of the present invention, and beprotected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features of the present invention will be more readily understoodfrom the following detailed description of exemplary embodiments thereofwhen read in conjunction with the accompanying drawings.

FIG. 1 is a side view of a guide cannula held by a cooperatingstabilizer according to embodiments of the present invention.

FIG. 2 is a schematic illustration of a guide cannula and stabilizer inline with a target spinal facet joint, with a combination tissue removal(denudement) and cauterization tool inserted according to embodiments ofthe present invention.

FIG. 3 is a side view of a surgical tool for spinal facet painalleviation therapies according to embodiments of the present invention.

FIG. 4A is an enlarged side perspective views of an exemplary externalstabilizer holding an exemplary guide tube, shown with the stabilizerwith a transparent body/wireframe to illustrate the underlying guidetube according to embodiments of the present invention.

FIG. 4B is a front view of the device shown in FIG. 4A.

FIG. 4C is a front view of the device shown in FIGS. 4A and 4B but withthe stabilizer shown in solid.

FIG. 4D is a corresponding enlarged side perspective view of the deviceshown in FIG. 4C.

FIG. 5A is a schematic illustration of a guide tube with a cover overthe vacuum ports according to embodiments of the present invention.

FIGS. 5B-5D schematically illustrates optional piercing elements thatmay be provided to open closed guide cannula fluid ports according toembodiments of the present invention.

FIG. 6A is a side perspective view of a stabilizer and tubeconfiguration according to embodiments of the present invention.

FIG. 6B is an end perspective view of the stabilizer and tubeconfiguration shown in FIG. 6A.

FIG. 7A is a partial cutaway top perspective view of a surgical toolaccording to embodiments of the present invention.

FIG. 7B is an end perspective view of a shaft with a surgical cauteryand tissue-scraping tool head according to embodiments of the presentinvention.

FIG. 8A is a schematic illustration of a circuit according toembodiments of the present invention.

FIG. 8B is a schematic illustration of a circuit with a reuserestriction circuit that can self-destruct certain components accordingto embodiments of the present invention.

FIG. 8C is a schematic illustration of a circuit with a combinationcautery and motor power source according to embodiments of the presentinvention.

FIG. 8D is a graph of exemplary power curves that an electrosurgical (RFpower source) generator can employ according to embodiments of thepresent invention.

FIG. 9A is an enlarged side perspective view of a sub-assembly of aworking tube (guide cannula) with a cooperating hand grip memberattached thereto according to embodiments of the present invention.

FIG. 9B is a section view of the sub-assembly shown in FIG. 9A.

FIG. 10A illustrates the sub-assembly shown in FIG. 9A used with adilation tube and k-wire according to embodiments of the presentinvention.

FIG. 10B is a section view of the cooperating components shown in FIG.10A.

FIG. 11A is an enlarged view of an exemplary hand grip member accordingto embodiments of the present invention.

FIG. 11B is an enlarged view of an opposing side of the hand grip membershown in FIG. 11A.

FIG. 12 is a schematic illustration of a kit for spinal facet surgicalprocedures to alleviate pain according to embodiments of the presentinvention.

FIG. 13 is an exemplary flow chart of steps that can be used to carryout surgical procedures according to embodiments of the presentinvention.

FIGS. 14A-14G illustrate cooperating components that facilitate a spinalsurgery according to embodiments of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention now is described more fully hereinafter withreference to the accompanying drawings, in which embodiments of theinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Like numbers refer to like elements throughout. In the figures, thethickness of certain lines, layers, components, elements or features maybe exaggerated for clarity. Broken lines illustrate optional features oroperations unless specified otherwise. The abbreviations “FIG.” and“Fig.” are used interchangeably with the word “Figure” in thespecification and drawings. One or more features shown and discussedwith respect to one embodiment may be included in another embodimenteven if not explicitly described or shown with another embodiment.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a,” “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. As used herein, phrases such as “between X and Y” and“between about X and Y” should be interpreted to include X and Y. Asused herein, phrases such as “between about X and Y” mean “between aboutX and about Y.” As used herein, phrases such as “from about X to Y” mean“from about X to about Y.”

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being “on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on,” “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “adjacent” another feature may have portions thatoverlap or underlie the adjacent feature.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if the device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

It will be understood that, although the terms first, second, etc. maybe used herein to describe various elements, components, regions, layersand/or sections, these elements, components, regions, layers and/orsections should not be limited by these terms. These terms are only usedto distinguish one element, component, region, layer or section fromanother region, layer or section. Thus, a first element, component,region, layer or section discussed below could be termed a secondelement, component, region, layer or section without departing from theteachings of the present invention. The sequence of operations (orsteps) is not limited to the order presented in the claims or figuresunless specifically indicated otherwise. In the claims, the word “a”with respect to an element is intended to include one or more of suchelements and is not limited to a single such element unless statedotherwise.

The term “about” means that the recited number or value can vary by+/−20%.

The term “sterile” means that the noted device or material meets orexceeds defined medical guidelines of cleanliness as is well known tothose of skill in the art to be substantially (if not totally) withoutcontaminants so as to be suitable for medical uses and/or comply withdefined medical guidelines, rules and/or regulations.

Embodiments of the invention are suitable for human or animal use, andare particularly suitable for human use.

The term “fluted” and derivatives thereof refer to recesses, typicallyflat or concave grooves, on one or more of the inner wall, outer wall,or shaft of a barrel, drive shaft, rotatable head or column of asurgical tool.

The term “denudement” and derivatives thereof refer to a procedure topolish, (gently) grind, scrape, file, grate, cleanse and/or rasp awaysoft tissue of facet joints to thereby denude tissue and uncover orexpose the underlying bone without cutting into or removing the bone(e.g., in contrast to a sharp cutting edge like a knife). The denudementtool can have a surface that has an abrasive texture and/orconfiguration which may include small teeth.

The term “debridement” and derivatives thereof refer to the removal ofsoft tissue associated with an end plate receptor region of a targetspinal facet joint including the synovial capsule and tissue scraping ofan outer boney surface of the joint.

Generally stated, embodiments of the invention allow spinal facet jointdebridement to remove the end plate receptor region which includes thesynovial capsule and outer surface of the joint. Once the synovialcapsule and outer surface of the joint are denuded, the nerves havenowhere to re-adhere to the joint and thus the joint is permanentlydenervated (communication between the facet joint and the brain isgone). In studies carried out by one of the inventors, pain relief ispermanent in 75-80% of patients.

While the joint continues to have arthritis, the patient's perception ofthe pain is gone as pain is what the brain perceives it to be and thepatient simply does not feel the spinal pain. The joints have no worsedecay then they would with the currently utilized RFL procedure sinceboth utilize a denervation technique where the pain signals are severedbetween the brain and the joint.

Advantageously, while the current RFL procedure is a temporary treatmentof pain, the spinal facet debridement procedure is a permanentalleviation of pain at the treated spinal facet joint. Thus, the spinalfacet debridement procedure is cost effective. For example, currently,people who undergo RFL procedures may have them performed around twice ayear for the duration of their lives, while the spinal facet debridementprocedure is done once for the affected area. As people age, they mayneed other areas of the spine treated; for example, a person who has alow back debrided may eventually need the neck debrided. This is similarto the current RFL, in which only a small segment of the spine is doneat one time for both patient comfort and time constraints. Usually twoor three levels, bilaterally, are performed for either procedure.

Referring now to the figures, FIG. 1 illustrates a guide cannula 30(also interchangeably termed a “guide tube” and a “portal”) and astabilizer 40 that snugly holds the guide cannula 30 while allowing auser to adjust a height of the tube below the stabilizer 40. That is,the stabilizer 40 can include a height adjustment member 44 thatcooperates with the guide tube 30 so as to allow a user to adjust wherethe stabilizer 40 holds the tube 30 thereby adjusting the height of thedevice 30 inside a patient body and/or below the bottom of thestabilizer 40 b.

The stabilizer 40 includes a portion with a tubular body 40 t with alower surface or base 40 b that has a larger cross-sectional or surfacearea than the tubular body 40 t and can reside against skin S of apatient (FIG. 2). The barrel 10 b of the surgical tool 10 (FIG. 2) canextend through a lumen 30 l of the guide cannula 30 while the guidecannula 30 is held in a desired height position by the stabilizer 40.

The tool head 15 can have a aperture that merges into a pin receivingchannel 11 (FIG. 12) for guiding placement over a pin or guidewire, forexample.

In the embodiment shown in FIGS. 1 and 4A-4D, the height adjustmentmember 44 can be biased to have a “normal” position whereby it snuglyreside against an outer surface of the tube 40 t and can extend inwardinside a window 40 w in the stabilizer tube 40 t. A user can pull,pinch, press, depress or otherwise release or loosen the lateralposition of the adjustment member 44 away from the outer surface of theguide cannula 30 thereby allowing the guide cannula 30 to be slid up ordown inside the stabilizer tube 40 t.

FIGS. 1, 2 and 4A-4D also show that the stabilizer 40 can include atleast one vacuum port 40 v (shown as a single vacuum port, but more thanone may be optionally used). The vacuum port 40 v can be configured as aflexible, rigid or semi-rigid tube segment 40 s that extends (typicallyradially) outward from the stabilizer tube 40 t that holds the guidecannula 30. The guide cannula 30 can include at least one fluid port 30p that is in fluid communication with the vacuum port 40 v duringoperation of the surgical tool 10. The vacuum port 40 v can connect to avacuum source 170 that can suction fluid from inside the guide cannula30, out a selected port 30 p and into the vacuum port 40 v.

With reference to FIG. 2, the spinal facet therapy delivery tool (e.g.,“debrider” tool) 10 has a head 15 that contacts target tissue and thetool barrel 10 b and/or head 15 is rotatable for denudement of thetarget tissue. The tool 10 can connect to a cautery generator 80. Thecautery generator 80 is also known as an “electrosurgical generator” and“RF power generator.” The vacuum port 40 v can connect to a vacuum orsuction source 170 via tubing 43.

The cautery generator 80 can be any appropriate power, electro-surgerygenerator including third party generators and/or a custom generatorthat is dedicated for use in spinal facet surgery, e.g., configured foruse only with the tools 10. If third party generators are used, the tool10 can include a control circuit C that can communicate with a selectedgenerator input so as to be able to operate with multiple differentgenerators. For example, a computer look up table can provide aselection of different defined generators 80 and the control circuit Ccan be used to provide the appropriate settings, automatically or formanual adjustment. The generator 80 may optionally be provided as acustom generator with the tool 10 or made available from an authorizedsupplier according to defined specifications of operation to meetregulatory guidelines for medical use and comply with Good ManufacturingPractices, for example.

As shown in FIG. 8C, in some embodiments the cautery generator 80 can beprovided in a combination unit or housing 80 h that also holds the motorpower source 80 m so that the tool 10 can have an electrical connectionto the combination unit for powering both functions during a medicalprocedure. The unit 80 h can thus provide cautery power to the surgicaltool 10 and electrical power to the tool 10 for the rotational motor Mof the device shaft or barrel. Having the generator unit 80 h provideboth the cautery and electrical power generation can eliminate thebatteries for powering the rotational motor, e.g., batteries are notrequired to be held onboard the body of the tool.

During a procedure, typically during or after a defined activecauterizing time, e.g., between about 10-30 seconds of activecauterizing time, with an exemplary cautery site temperature of about302 degrees F., the vacuum port 40 v, cooperating with the guide cannula30, can be configured to vent heat H from inside the guide tube 30(e.g., the lumen 30 l) outside the patient body and maintain a maximumtemperature inside the guide cannula 30 to be at about 122 degreesFahrenheit (degrees F.) (e.g., no greater than +2 degrees) or lower,e.g., typically below 122 degrees F. and at or above about 80 degrees F.Animal laboratory testing or cadaver testing can be used to test the maxtemperature using the vacuum port on the stabilizer 40 and cooperatingguide tube 30 with the cauterizing surgical tool 10. By way ofcomparison, temperatures inside the lumen 30 l of a guide tube 30, heldby a stabilizer 40 (without the vacuum exhaust 40 v that is in fluidcommunication with the lumen 30 l) during cauterization with atemperature at the cauterization site at about 300 degrees F. can reachtemperatures above 122 degrees F., more typically about 140 degrees F.The target temperature for humans (away from the cautery site) is under124 degrees F., such as between 80-124 degrees F., between 80-123degrees F. or between 80-122 degrees F.

FIG. 3 illustrates a tool 10 with the barrel 10 b which is rotated by anonboard motor M powered by either at least one battery (shown as a setof batteries pack B, FIG. 7A) or a DC or AC power source that is remotefrom the tool 10 such as in a unit housing 80 h with the electrosurgicalcautery generator 80 c (FIG. 8C).

The tool 10 can include a cord 13 that connects to the cautery generator80. The tool 10 can have a pistol grip 10 p with a latch 10 d thatallows a user to easily detach or remove the batteries as a pack (wherebatteries area used) so as to be single-use engineered.

The tool 10 can also be configured with a circuit C (FIGS. 8A-8C) thatautomatically destroys components to inhibit reuse.

Referring to FIGS. 4A-4D, 9A and 10A, for example, the heat exhaustports 30 p can be longitudinally spaced apart along a length of theguide cannula 30. Although shown as vertically aligned, they may belaterally offset and may be clustered rather than regularly spacedapart. Also, although shown as a plurality of ports 30 p, the guidecannula 30 may include a single port 30 p.

Referring to FIGS. 4C and 5A, in some embodiments, the ports 30 may beprovided in a closed state prior to user selection of a desired port orports for a particular procedure or patient. The ports 30 p may includea sealant or cover 33 (FIG. 5A) that is thermally suitable that attachesto an inner and/or outer wall of the guide cannula 30 and extends overone or more of the ports 30 p. The ports 30 p may be preferentiallyscored 30 s as shown in FIG. 4C, but intact so as to be sufficientlysealed to inhibit gas exhaust when intact. The ports 33 can besubstantially or totally sealed with thinner wall perimeter segmentsthat can be detached to expose a port 30 p to allow a user to push opena desired port 30 p during or prior to a procedure. FIG. 5B illustratesthat where a cover 33 is used, the cover 33 may be pierced, punctured orpushed open using a shaped end 40 e of a movable arm of the vacuum port40 v. FIG. 5C illustrates a separate tool 41 that can be inserteddirectly into a port 30 p or into the arm of vacuum port 40 f to reachthe cover 33 over a desired port 30 p may be included in the surgicaltool kit 75 (FIG. 12).

FIG. 5D illustrates that a cover or seal (e.g., a cap) 42 can beattached to the vacuum port 40 v. The cap 42 can also or alternativelybe attached to a body 41 with an end 42 e that can push, pierce orotherwise open the port 30 p or the cover 33 over a desired port 30 p. Auser can select and open a port 30 p that is at a height that isappropriate for use for a particular procedure (e.g., depending on theheight of the guide cannula relative to the stabilizer 40).

It is preferred, but not required, that the port 30 p that is used for aprocedure align longitudinally and laterally with the vacuum port 40 v.However, the ports 30 p, 40 v may be misaligned as long as there issufficient fluid communication to provide for heated exhaust gases to beremoved to keep the temperature in the guide cannula 30 (at least thepart that is in the patient body and proximate the skin S) at 122degrees F. or below without requiring other active cooling inputs.

FIGS. 6A and 6B illustrate the height adjustment/lock member 44 caninclude a finger 44 f, that can flex back and forth in a direction thatcan be perpendicular to the long axis of the guide cannula 30 toselectively release and lock the guide cannula 30 at a height positionas indicated by the arrow. FIGS. 6A and 6B also show that the base 40 bcan have a light weight configuration with a plurality of spaced apartapertures 40 a. Although shown as circumferentially, regularly spacedapart according to some embodiments, the apertures 40 a can beconfigured with other geometries and may be irregularly spaced apart.The apertures 40 a can be provided as 6 (six) relatively large aperturesas shown, lesser apertures (not shown) or a more dense number of smallerapertures (also not shown).

FIG. 7A illustrates the tool 10 can have an onboard control circuit Cwith a user activation input (shown as a push button) 62. The electricmotor M turns the shaft 18, which turns the barrel 10 b and rotates thebarrel and cautery element on the head 15.

The circuit C can include at least one processor P that controlsoperational parameters of the device 10 and/or can monitor for definedinputs such as a defined wattage range of a cautery generator 80. Inpreferred embodiments, the maximum wattage of thecautery/electrosurgical generator 80 is between about 40 Watts to about60 Watts, which is much less than maximum wattages that many surgicalcautery generators can provide. Thus, the circuit C can be configured toprevent operation, disable operation, turn power off to prevent heatingand/or rotation, and optionally send a warning or alert to a user toadjust the wattage if the wattage is above the defined limit, e.g., 40Watts, 50 Watts or 60 Watts, with a power curve having a maximum outputwattage of between 150V-230V, e.g., 150V, 160V, 170V, 180 V, 190V, 200V,210V, 220 V or 230V and a peak maximum current of 1000 mA.

As shown in FIG. 8D, in some embodiments, the cautery generator 80 canprovide the cautery output to the tool 10 using a defined power curve.The graph illustrates three exemplary power curves. The operationalpower curve can have a maximum voltage of 180 V, 200V or 220V, a maximumcurrent of about 1000 mA and a maximum output wattage of 40 W over0-3000 Ohms The cautery output can be monopolar, in some embodiments.

The electrosurgical generator 80 can employ a Field-Programmable GateArray (FPGA) algorithm for controlling the RF output of theelectrosurgical generator 80 for the surgical tool 10. The generator 80may use an FPGA algorithm with a power curve with defined maximum valuesof power, voltage, current. FPGA controls are well known, see, e.g.,U.S. Pat. No. 6,142,992, the contents of which are hereby incorporatedby reference as if recited in full herein.

In some embodiments, the circuit C can be totally onboard the tool body10 b, totally onboard the cautery generator unit 80 or distributedbetween the tool body 10 b and the generator unit 80. The circuit C maybe distributed in remote devices using an intranet and/or the internetsuch as a remote server in a distributed network such as a CLOUD-basednetwork.

FIG. 8A illustrates an example of an onboard circuit C that can have atleast one processor P (which can include a digital signal processor), awattage control circuit W in communication with the cautery generatorinput 80 i which can include a sensor 80 s that can be monitored by thecircuit W. The processor P can control a switch 76 that deactivates thetool 10 and/or turns off or inactivates power to the motor M. Theprocessor P can send a warning to an onboard or remote display or anaudile alert to allow a user to adjust the cautery generator wattagesetting if the wattage is above a defined limit, typically above 50Watts. This control may allow for use with a number of differentconventional cautery generators in different clinics or hospitals and/orin different countries.

In some embodiments, the head 15 can have an electro-conductive member15 e and/or outer surface to which electrical energy is supplied (inbipolar or monopolar mode), thereby permitting the head 15 to cauterizetissue. The electro-cauterization can be any suitable cautery source,typically RF power, although other electrical sources may be used. Foradditional discussion of components of a suitable combination spinalfacet debrider tool 10, see, e.g., U.S. Pat. No. 8,167,879; andco-pending U.S. patent application Ser. No. 14/257,490, the contents ofwhich are hereby incorporated by reference as if recited in full herein.

The distal end portion of the therapy delivery tool 10 with the head 15can have a maximal outer diameter that is between about 5-15 mm, such asabout 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm,about 11 mm, about 12 mm, about 13 mm, about 14 mm and about 15 mm,typically between 10-12 mm.

The procedure can be done via conscious sedation and local anesthesia orgeneral anesthesia as per the surgeon's and patient's preference. For,example, conscious sedation can be used with a remifentanyl mixture. Thespinal region is typically prepped and draped accordingly. Utilizingfluoroscopic or other suitable imaging guidance, the facet joints J thatmay be treated can be identified.

To facilitate a minimally invasive treatment, a semi-rigid or rigidguidewire and/or pin 20 (e.g., a Steinman pin) (FIG. 12) with a diameterof approximately 1 mm can be inserted through skin S and tissue of apatient into the target facet joint region. The guidewire/pin 20 can betapped into place with a small hammer or other suitable device. A smallincision, typically between about 0.25-1 inch, e.g., about ½ inch orabout ¾ of an inch can be made about the pin 20. In other embodiments,the incision can be made before or during the insertion of the pin 20.

The guide cannula 30 (sometimes also called “a working cannula” or“portal” as discussed above) can be inserted into the patient so that adistal end thereof 30 d (FIG. 1) resides proximate the target facet siteJ (FIG. 2). The guide cannula 30 can be inserted over the guide pin 20to help position the guide cannula 30 in the body. Typically, as shownin FIGS. 10A and 10B, the guide cannula 30 is inserted over a dilationtube 50 which is first inserted over the guide pin or wire 20.

The (external) stabilizer 40 holds the guide cannula 30 in position. Theguidewire/pin 20 and dilation tube 50 may be removed before or afterplacement of the stabilizer 40.

In some embodiments, as shown in FIGS. 9A, 9B, 10A, 10B, 11A and 11B, ahand grip member 200 (sometimes also called “portal driver”) can beattached to the guide cannula 30 to cause the distal end of the guidecannula 30 d to cut through adjacent tissue thereunder to be able tohave the distal end of the guide cannula 30 d remain at the joint J(FIG. 2) even when the pressing force from the hand grip member 200 isremoved. That is, when just inserting a guide cannula 30 to the locationJ over the dilation tube 50, the underlying tissue may have sufficientresiliency to resist the placement of the distal end of the guidecannula 30 d so as to “reset” or relocate the location of the distal endof the guide cannula to be about 2-20 mm from a bone surface of thetarget J when the guide cannula 30 is merely pushed into a targetposition over the dilation tube 50 and/or pin 20. To assure proper andclose placement of the distal end of the guide cannula 30, a user canmanually rotate and press inward against the hand grip member 200 tothereby cause the distal end of the guide cannula 30 to cut through thetissue proximate the joint J.

Typically, once the distal end of the guide cannula 30 is proximate atarget site (e.g., within 0.001 mm to about 5 mm of the bone at thejoint J), a user grips the member 200 while concurrently pushing androtating the member 200 to carry out the desired placement of the distalend of the guide cannula 30 d. There is no need to twist the hand grip200 while pressing against it for an entire insertion length. Also, theamount of pushing force applied by a hand of a user while twisting themember 200 is relatively low and easily manually applied, typically thepressing force is in a range of about 5 to about 50 Newtons. It is alsocontemplated that the twist can be in a single direction and less thanone revolution to place the device 30 d.

Referring to FIGS. 9A, 9B, 10A, 10B, 11A and 11B, the hand grip member200 can allow a user to apply an inward force F concurrently with arotation R as indicated by the arrows in FIG. 9A. In some embodiments,the hand grip member 200 can be releasably affixed to an outer endportion of the guide cannula 30. In some embodiments, the member 200 canbe detached from the guide cannula 30 and may be removed before placingthe stabilizer 40. In some embodiments, the hand grip member 200 canremain in position and cooperate with the stabilizer 40 during asurgical procedure. In some embodiments, the hand grip member 200 may bean integral part of the guide cannula 30.

As shown in FIGS. 9A, 9B, 11A and 11B, for example, the hand grip member200 can have a tubular portion 202 with a cylindrical channel 204 thatsnugly slidably receives an upper end portion of the guide cannula 30.The channel 204 can be a through-channel as shown in FIGS. 10B and 11A,for example.

The hand grip member 200 can have a hand-grip 205 that resides above thetubular portion 202 and that has a larger radial extent than the tubularportion 202. The hand grip 205 can be substantially circular, typicallywith a diameter that is greater than that of the guide cannula 30, suchas between 2× and 5× greater than the diameter of the guide cannula 30.The hand grip 205 may include an outer perimeter with spaced apartprotrusions 207 that can provide finger grip features and/or anti-slidesurfaces. The cylindrical channel 204 can have an interiorcircumferentially extending stop 200 s that resides between opposingupper and lower portions of the channel 204, typically below butadjacent the hand grip 205. The proximal end the guide cannula 130 p canabut against the stop 200 s as shown in FIGS. 9B and 10B.

As also shown in FIGS. 9A and 9B, the tubular portion 202 of the handgrip member 200 can have an inner wall with at least one longitudinallyextending recess 208 that matably receives a correspondinglongitudinally extending protrusion 133 on the outer wall of the guidecannula 30, which may optionally hold the exhaust ports 30 p. Theopposite configuration may also be used, e.g., the inner wall of thetubular portion 202 can have the protrusion while the guide cannulaouter wall can have the recess or combinations of these or otherconfigurations that allow the fixation for rotation of the guide cannula30 with the hand grip member 200.

As shown in FIGS. 10A and 10B, the hand grip 200 can be attached to theguide cannula 30 and receive a k-wire or pin 20 as well as the dilationtube 50 in the channel 204. The proximal end 130 p of the guide cannula30 can reside under the hand grip 205 with the proximal end 150 p of thedilation tube 50 above as shown. In other embodiments, the guide cannula30 can extend through the hand grip 205 and reside above the hand grip205 along with the dilation tube and guide-wire or pin 20 (FIGS. 10A,14A-14F). Typically, at least the k-wire or pin 20 remains in the guidecannula 30 as a user rotates and pushes against the hand grip member 200to cut through tissue to position the guide cannula distal end 30 d atthe target site J so that it remains there upon removal of the forceapplied to the hand grip member 200 and/or removal of the hand gripmember 200 from the guide cannula 30 (for detachable versions). Thestabilizer 40 can be positioned on the guide cannula 30 after it is inproper position or before or during. In some particular embodiments, thehand grip member 200 can be detached from the guide cannula 30, then thestabilizer 40 placed on the patient and attached to the guide cannula30.

FIGS. 10A and 10B also illustrate that the k-wire or pin 20 can includevisible markings 120 for a visual reference that a user can see to alignwith a top or proximal end of the guide cannula 130 p and/or dilationtube 50. As the k-wire or pin 20 touches bone at the target treatmentsite J, assessment of position of the distal end of the guide cannula 30d and/or dilation tube 50 can be made relative to the visible markings120. The visible markings 120 can be striations, notches, embossments,color markings, graduated measurement indicia marks or combinations ofsame. The upper end portion of the dilation tube 50 may be visuallytransmissive, such as translucent or transparent. The upper end of thedilation tube may also include visual reference indicia markings (notshown).

The stabilizer 40 can be configured to provide a depth stop for thetherapy delivery tool 10 and optionally structural, such as rotationalstabilization for the tool barrel 10 b proximate the skin entry site S.The stabilizer device 40 can slidably receive and releasably hold theguide cannula 30 and tool barrel 10 b and may be used without requiringthe guide pin 20, e.g., the guide pin 20 may not be used or may bewithdrawn prior to or after the stabilizer 40 is in position on thepatient while holding the guide cannula 30 at a desired stop depth.

As shown in FIGS. 1, 2, 4A-4D, the stabilizer 40 can have a bottom 40 bthat resides against skin S of the patient, either directly orindirectly. The bottom 40 b can have a width W of between about 2-6inches, typically between about 3-5 inches, such as about 3 inches,about 3.5 inches, about 4 inches, about 4.5 inches and about 5 inches.The bottom 40 b can have a larger width than the width of the stabilizertube 40 t which has a through-channel 40 c for the guide cannula 30and/or tool 10. The stabilizer tube 40 t typically has a smaller heightthan the height of the barrel 10 b (FIG. 12) of the therapy deliverytool 10 and/or height of the guide cannula 30. In some particularembodiments, the stabilizer 40 can have a height that is between about2-10 inches, typically between about 3-6 inches, such as about 3 inches,about 3.5 inches, about 4 inches, about 4.5 inches, about 5 inches,about 5.5 inches, and about 6 inches, although the stabilizer may haveother height dimensions.

As shown in FIGS. 1, 2 and 4A-4D, the stabilizer 40 can releasably,slidably engage the guide cannula 30. The stabilizer 40 can beconfigured with the height adjustment member 44 configured to releasablylock against the outer surface of the guide cannula 30. The lockingengagement 44 can be provided using a physical lock member (e.g., aclamp or other suitable lock) or a locking configuration, e.g.,frictional engagement or other locking configuration. The stabilizer 40and cannula 30 engagement can be through any suitable physicalengagement that allows the stabilizer 40 to lock against the cannula 30directly or indirectly and preferably also allows for the heightadjustment of the cannula 30 in the stabilizer 40.

The therapy device 10 can be configured such that when the elongatebarrel 10 b is inserted fully through the guide cannula 30 in anoperative configuration, the head 15 and/or distal end of the therapydevice 10 d extends beyond the front or distal end 30 d of the cannula30

only by between about 2 mm to about 7 mm, such as about 2 mm, about 2.5mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm,about 5.5 mm, about 6 mm, about 6.5 mm or about 7 mm. Thus, thestabilizer 40 locks the cannula 30 in a longitudinal position and thestabilized/locked position of the cannula 30 relative to the skin of thepatient S based on the stabilizer 40 keeps the distal end 10 d of thebarrel 10 b and/or head 15 at the target site and acts as a stop to keepthe head 15 from moving deeper into the body.

As shown in FIG. 2, the top of the guide cannula 30 t and a toolinterface 10 i can cooperate to keep the tool barrel 10 b can define ahard stop and keep the tool barrel 10 b from moving further inwardrelative to the cannula 30. The cannula and tool interface 10 i can beprovided in any suitable configuration. In the example illustrated, theinterface 10 i is shown based on the shape of the tool and top of thecannula 30 t, e.g., through abutting contact to provide a physicalinterference/stop.

The stabilizer 40 may optionally provide some structural support for theguide cannula 30 and/or tool 10 at the entry site. As noted above, thestabilizer 40 can have a bottom 40 b that has a greater width/surfacearea than the primary body 40 b. The width of the bottom 40 b can belarger than the width of the cannula 30 by between two-ten times.Typically, the stabilizer bottom 40 b has a width that is between about1-6 inches, more typically between about 3 to about 5 inches. Thestabilizer bottom 40 b can be thin, typically between about 1-10 mm,more typically between about 2 to about 4 mm. The bottom 40 b can besemi-rigid or rigid. The bottom 40 b can be configured to conformablyreside against the skin of the patient.

As shown in FIG. 4C, the guide cannula 30 can have visual depth markings30 i, typically in an incremented, graduated scale. The scale can be inmicrons or millimeters or other defined increments of length position.In some embodiments, the depth indicia marking 30 i may be color-codedto reflect shorter versus longer depths or having depth indicia forvisual correlation of depths for different treatment levels of thespine.

The longitudinal position of the guide cannula 30 relative to thestabilizer 40 can be adjustable to allow a clinician to adjust for aspecific patient and/or target joint to thereby adjust the intrabodydepth of the therapy tool delivery head 15 once inserted into the guidecannula 30 that is locked into its desired position by the stabilizer40.

In some embodiments, a dilation tube 50 (FIGS. 10A, 10B, 12) can be fedover the guide pin 20, typically after the guide pin distal end isanchored to the treatment site of the facet joint J. The dilation tube50 can be configured with a plurality of cooperating componentsincluding an inner tube with a distal end having a tapered end (e.g., abullet-like shape). The tapered (bullet shaped) end can be inserted downto the facet joint J. The tapered end 50 b can be sized and configuredto push through the muscle to create an opening, preferably withoutcutting the muscle.

Optionally, the cannula 30 can slidably extend and reside over thedilation tube 50. The cannula 30 may be sized and configured to snuglyreside against the tube 50 so that it does not freely slide along thetube 50 without pushing by a user. The cannula 30 can be positionedupstream of the tapered end on the dilation tube 50 prior to insertingthe dilation tube in the body. In other embodiments, the cannula 30 canbe separately inserted over the dilation tube 50 after the dilation tube50 is inserted into the body. In any event, once the tapered end reachesthe facet joint J, the guide cannula 30 (e.g., working tube) can bepushed down to the facet joint J so that the distal end 30 d of thecannula 30 resides at the facet joint. The dilation tube 50 can then beremoved, leaving the cannula 30 in position.

The stabilizer 40 can have an open channel 40 c that allows the dilationtube 50 and/or the guide cannula 30 to extend therethrough.

The guide cannula 30 is typically rigid. The guide cannula 30 can beformed or include materials that may be compatible with autoclaving forsterilization. The guide cannula 30 can be metallic or other non-toxicand/or biocompatible material that is sufficiently rigid and that may behigh-temperature (autoclave) heat-resistant or suitable for the thermalexposure during cauterization. Other sterilization protocols may be usedthat do not require heat. The guide cannula 30 can be metallic (and ifso can have an electrically insulating material over an end portion orsurface thereof) or may be polymeric or other plastic material withsufficient rigidity to provide the guide path for the tool 10. Oneexemplary material, by way of example only, is Polyether ether ketone(PEEK).

In some particular embodiments, the guide cannula 30 may comprise astainless steel material with an inner surface having an electricallyinsulating material. The electrical insulating material can beconfigured to inhibit arcing with the electro-cautery output, e.g., RFenergy at the head 15, when the tool is configured to apply RF energyfor the cauterization. The electrical insulating material can beprovided by an internal sleeve or coating or otherwise. The insulatingmaterial may reside on only a distal end portion of the guide cannula 30or over an entire inner surface of the cannula 30. The electricallyinsulating material may optionally reside on the outer surface of theguide cannula 30, such as on the distal end thereof.

It is also noted that the guide pin/wire 20 is optional and that thedilation tube 50 may be inserted without requiring the use of the guidewire/pin 20. Also, where used, the guidewire/pin 20 may extend throughthe cannula 30 rather than the barrel of the tool 10 b and is notrequired to extend along a centerline of the device 10 b, 30. Forexample, the cannula 30 can have a guidewire channel residing about aperimeter segment.

The stabilizer 40 can be positioned prior to, during or after insertionof the guidewire/pin 20 (where used), the dilation tube 50 and/or thecannula 30.

The tool head 15 can be rotated to denude tissue until bone at thetarget spinal facet joint is reached. In preferred embodiments, therotation of the head 15 can be automatic using a motor M (FIGS. 7A, 8C)with a drive shaft 18 (FIGS. 7A, 7B) connected to the therapy tool head15. However, in some embodiments, the denudement head 15 can be manuallyrotated. The therapy tool head 15 is also configured to cauterize thesoft tissue during and/or after the denuding.

As shown in FIGS. 2, 7A and 7B, in some embodiments, the tool 10 canhave an elongate barrel 10 b and/or shaft 18 with a length sufficient toreach the target intrabody spinal facet site. The length of the barrel10 b and/or shaft 18 can be between about 100 mm to about 150 mm.

The cannula 30 can have a diameter that is slightly larger than theouter diameter of the shaft 18 and/or tool barrel 10 b, e.g., betweenabout 0.1 mm to about 1 mm to allow snug sliding entry of the tool 10.The tool 10 can have various form factors. The barrel 10 b may rotate orbe static. The barrel 10 b can form part of the drive shaft 18 androtate with the head 15 as an integral or separate component thereof orsubstantially or totally encase the drive shaft 18 of the rotating head15.

During use, the proper “stop” for a treatment and/or denuding action canbe confirmed by a manual tactile feel since the debrider tool 10 can bemade to remove the soft capsular tissue and superficial lining of thejoint J but when the bone is reached by the head 15, the tool 10 willnot advance or there will be increased resistance and the surgeon can“feel” in a tactile feedback manner that he or she is up against thehard surface of the bone. However, as noted herein, sensors can be usedto provide feedback/electronic control.

The denuding of target soft tissue with the tool 10 can have a shortduration (with the active rotation of the debridement tool head) that isbetween about 10 seconds to about 2 minutes long, typically betweenabout 20 seconds to about 40 seconds, on average.

The tool 10 can be configured to continuously rotate the head 15 duringboth cauterization and subsequent (light) tissue scraping/cleansing uponcontact with bone at the facet joint J. In some embodiments, the tool 10can be configured to discontinuously rotate the head 15 and/orinterleave the cauterization with the rotation.

Once the soft tissue is denuded, the tool head 15 can be rotated withsufficient force and time to contact the outer surface of the bone underthe denuded tissue for a desired short time, e.g., between about 10seconds to about 2 minutes, more typically between about 10 seconds toabout 60 seconds, to cleanse an exposed outer surface of the bonethereat substantially without removing bone. The short tissuecleansing/scraping time, post-cauterization (e.g., post-denuding), canbe controlled with an auto-shutoff for the tool rotation and can betimed based on user or electronic (auto) shut off of the cautery/burn orbased on sensor feedback of contact with bone.

The tool 10 can be rotated with the same rotational speed for the bonesurface cleansing relative to the denuding action or with a differentrotational speed and/or force for the bone surface cleansing relative tothe denuding action. In some embodiments, the tool 10 has a firstdefined rotational speed range for the denuding and a different definedrotational speed range for the cleansing. The transition from denuding(with or without cauterizing) to cleansing can be automatic or manual.If automatic, a sensor can trigger the transition to a different speedand/or to terminate the power to stop the cauterizing action. If manual,a user interface (UI) via a control such as a switch or a voice promptto a control circuit can direct the change in operation, e.g., slowrotation and stop cautery/burn.

In some embodiments, the tool 10 can be configured to apply thecauterization without rotation of the head 15 then cleanse/tissue scrapewith the rotation of the head 15. This may be particularly suitable forlaser, ultrasound or cryo-ablation configurations.

As shown in FIG. 7A, by way of example only, in some particularembodiments, the different speeds can be selectively applied by the uservia at least one user input 61, such as denude and cleanse mode controlinputs on the tool 10 that are in communication with the control circuitC and motor M. The inputs 61 may be a single physical input comprisingone or more UI 61, such as knobs, buttons, triggers, or GUI inputs on aminiature touch screen display onboard or in communication with the tool10. The UI can comprise voice-based inputs/commands, e.g., “STARTDENUDE, START/STOP CAUTERIZE, START/STOP SCRAPE” and the like.

The different speeds for the cleanse and denude modes (where both modesare used) may be automatically applied by the control circuit 50 basedon input from the sensor, where used. In some embodiments, the cleansemode has a 10-100% faster rotation speed than the denude mode while inother embodiments, the cleanse mode has a slower rotation speed (e.g.,10-100% slower) than the denude mode.

The speed of the therapy delivery tool head 15 (e.g., a tissue scraperand cautery head) can be relatively low to avoid cutting into the bone.Most orthopedic burrs will operate up to 60,000 rpm which can be hard tocontrol and can dig into the bone. Thus, lower rotational speeds aredesired for the denuding and/or cleanse modes or action. The objectiveis to sweep the tissue off the bone and not drill into the bone duringthe cleanse mode. Thus, in some embodiments, for either and/or bothdenuding and cleansing of the bone, a speed of below about 5000 rpm maybe appropriate, typically between about 10 rpm to about 5000 rpm, andmore typically between about 10-1000 rpm. If the tool shaft or barrel isrotated during cauterizing, the speed may be different for thecauterizing, the denuding and the tissue cleansing/scraping. In someembodiments, the speed for each is between about 10 to about 5000,including about 125 rpm, about 150 rpm, about 200 rpm, about 250 rpm,about 300 rpm, about 350 rpm, about 400 rpm, about 450 rpm, about 500rpm, about 550 rpm, about 600 rpm, about 650 rpm, about 700 rpm, about750 rpm, about 800 rpm, about 850 rpm, about 900 rpm, about 950 rpm,about 1000 rpm, about 1500 rpm, about 2000 rpm, about 2500 rpm, about3000 rpm, about 3500 rpm, about 4000 rpm, about 4500 rpm and about 5000rpm.

In some embodiments, the speed is low speed for one or both the denuding(with or without cauterizing) and the cleansing. The term “low speed”means between about 10 rpm to about 100 rpm, including about 10 rpm,about 15 rpm, about 20 rpm, about 30 rpm, about 40 rpm, about 45 rpm,about 50 rpm, about 60 rpm, about 70 rpm, about 80 rpm, about 90 rpm andabout 100 rpm.

While not necessary, the tool 10 can have a cleanse run mode thatrotates the therapy delivery tool head 15 at a slower speed than adenuding speed. In some embodiments, the tool 10 can have asubstantially constant rpm with a controlled maximum output of maximumoperational capacity at full speed of between about 10 rpm to about 5000rpm, typically between about 10 and 200 rpm, and more typically with amaximum rotational speed of between about 10 rpm to about 100 rpm.

As discussed above with respect to FIG. 8A, the tool 10 can include acircuit C that has a speed limiter control 77 to insure that the maximalrotational speed allowed is between about 10-5000 rpm. The use ofproperly sized gears/clutches, speed governors, electronic cut offsensors or other mechanisms can be used to control the maximal speed.

The tool 10 can be configured to have a maximum speed (at full speed)that is between about 10 to about 5000 rpm, typically between about10-1000 rpm such as between about 10-500 rpm or between about 10-100 rpmincluding about 40 rpm, about 45 rpm, about 50 rpm, about 55 rpm, about60 rpm, about 65 rpm, about 70 rpm, about 75 rpm, about 80 rpm, about 85rpm, about 90 rpm, about 95 rpm and about 100 rpm.

In some embodiments, a viewing scope can be placed in the cannula 30 orin an adjacent cannula or port (not shown) to allow real time viewing ofthe spinal joint J during the therapy.

The denuded soft capsular tissue can be suctioned via vacuum orotherwise removed by the spinal facet therapy (e.g., debrider) tool 10and/or via the guide cannula 30 and vacuum port 40 v of the stabilizer40 or with another tool. In some embodiments, the tool barrel 10 b canbe in fluid communication with an irrigation source and/or avacuum/suction source. The tool barrel 10 b can comprise an irrigationchannel and a suction/vacuum channel with respective ports on the distalend of the tool 10 d (see, FIGS. 25C and 26 of the co-pendingapplication incorporated by reference hereinabove). A single channel canbe used for both irrigation and suction where both functions areprovided. In some embodiments, no tissue removal is required.

The surgical site J can be flushed out with saline or other suitablecleansing liquid and suctioned and removed. The flushing of the site canbe carried out using the tool 10 or without the tool 10. If the latter,the tool barrel 10 b can reside in the cannula 30 during the irrigationand/or suction. The cannula 30 may remain in place during the flushingor removed before this action. The stabilizer 40, where used, can beremoved before or after the guide cannula 30. The therapy delivery tool10 can be removed before, after or with removing the cannula 30. Theguide pin 20 can be removed before, after or with the tool 10 and/orcannula 30 (or even earlier if not needed according to some embodiments,for example).

This procedure can be repeated for each joint selected for treatment.Typically, between two and six joints J can be treated at one therapysession.

In some embodiments, to save time, all of the guide pins 20 on one sidefor each joint J can be placed before any incisions and/or beforedebriding at any level. Sterile surgical tape such as 3M™ Steri-Strips™and/or a small suture (or surgical glue) can be placed to close arespective incision wound once the therapy is complete.

Post-pin placement, the entire spinal facet treatment procedure for onejoint J can take between five to fifteen minutes. The procedure can bean outpatient procedure and the patient can typically walk the same daywith recovery over a week to let the surgical sites heal.

FIG. 12 illustrates an example of a spinal facet debridement surgicaltool kit 75. As shown, the kit 75 can include a package 75 p withsterile components that facilitate the surgery. The kit 75 can include adebrider tool 10 (which can be the entire therapy delivery tool 10 or aconsumable, single use disposable or multi-use barrel 10 b), optionallya plurality of guide pins 20 ₁, 20 ₂ (shown as two, but one or more thantwo can be provided, or the pins can be provided separately outside thekit), a dilation tube 50 and at least one guide cannula 30 (or workingtube), and the stabilizer 40. The kit 75 may also include the hand gripmember 200. While shown as kits with all the noted components forfacilitating ease of surgical preparation, the components may beprovided as separate units or sub-sets.

The guide cannula 30 can be provided pre-attached to the dilation tube50 or hand grip 200, or may be provided as a separate unassembledcomponent. For bilateral and/or multi-level procedures, more than oneguide cannula 30 and, where used, more than one stabilizer 40, may beincluded, and if so, may be labeled for right and left sides and/or forindicating spinal treatment levels. The guide pins 20 can be provided ina common size or different sizes, typically with a diameter that isbetween about 0.75-1.25 mm, more typically about 1.0 mm.

FIG. 13 is a flow chart of exemplary actions that can be used to carryout a spinal facet treatment to alleviate pain associated witharthritis. A guidewire/pin is typically inserted into a target spinalfacet joint over a synovial capsule of a spinal facet joint (block 105).A dilation tube with a distal end having a tapered bullet shape isinserted over the guide pin to dilate an entry path to the target spinalfacet joint through muscle (block 110). A cannula is slidably advancedover the dilation tube to rest against the target spinal facet joint(block 115).

A hand grip can be attached to the guide cannula (block 116) before,during or after the advancing step. A user can concurrently rotate andpush the hand grip to thereby rotate and push the distal end of theguide cannula to cut through local tissue and position the distal end ofthe guide cannula at the target intrabody site (block 117). The dilationtube with the bullet shape can be removed, as can the hand grip andoptionally the k-wire/pin (in no particular order), leaving the guidecannula with an open channel extending therethrough in position (block120). An external stabilizer can be placed against the skin of thepatient prior to, during or after the guide cannula is advanced (block118). In some particular embodiments, the stabilizer is placed on thepatient after the hand grip and/or dilation tube are removed.

An elongate debridement tool with a denudement head having cauterizationcapability (“combination tool”) is provided (block 125). The combinationtool is inserted into the cannula such that the head resides against asurface of a target spinal facet joint (block 130). Soft capsular tissueand a superficial lining of the target spinal facet joint are denuded byrotating the head (block 135). Tissue at the target joint is cauterizedusing the head (block 140). Fluid is suctioned from the guide cannulathrough a vacuum port in the stabilizer out of the patient during thecauterizing (block 141) to thereby reduce heat in the guide cannula.

The treated joint can be flushed and suctioned. The therapy delivery(e.g., debrider) tool, cannula and guide pin can be removed and theincision entrance closed (block 145).

In some embodiments, the denuding and/or cauterizing can be carried outusing a low rotation speed for the rotatable tool head (block 137).

In some embodiments, a plurality of guide pins can be inserted, one foreach different target spinal facet joints (block 106). Steps 110, 115,120, 130, 135, 140 and 145 can be repeated at each respective differentspinal facet joint, typically between 2-6 joints, including 2 joints, 3joints, 4 joints, 5 joints and 6 joints (block 107). Usually two orthree levels, bilaterally, are debrided during a single surgicalsession.

The denudement typically lasts between about 10 seconds to 3 minutes(average), more typically between about 20 seconds to 40 seconds(average), and the entire procedure (post pin placement or including pinplacement) for one joint can be carried out in about 5-15 minutes(typically bilaterally per joint) (block 147).

The head 10 can be configured to denude and cauterize soft tissue at thetarget spinal facet joint either serially (e.g., intermittently orinterleaved) and/or concurrently. The tool 10 can allow a user to selectwhen to cauterize or it can be configured to automatically cauterizeduring the entire denuding action, during a portion of the denudingaction, or after a denuding action.

In some embodiments, the method can include electronically sensing whendenuding is complete upon contact with bone under the capsular joint(block 137). The method may optionally include electronically generatingan audible or visual alert to a user when the head contacts the boneand/or when the denuding of soft tissue is complete (block 138).

In some embodiments, the target spinal facet joint is a lumbar facetjoint and the cannula 30 and debridement tool 10 can be inserted in alumbar region at between a 10 to about a 40 degree angle, typicallybetween about 20-30 degrees for this region (block 133). Other levels,e.g., cervical and thoracic debridement may be at other angles typicallybetween about 0 to about 10 degrees.

It will be appreciated that angulation of the tool 10 can changedepending on scoliosis, etc. Typically, the lumbar region is betweenabout 10 to about 40 degrees as noted above. However, the angulation isappropriate so as to be perpendicular to the target spinal facet jointsurface, which is usually about 10 to about 40 degrees laterally in thelumbar region and between about 0 to about 10 degrees laterally in thethoracic and cervical regions.

In some embodiments, the order of use of the components where thestabilizer 40 is used can be: insert the guide pin 20, then insert thedilator tube 50. Next, the stabilizer 40 can be placed on the skin Sover the guide pin 20 and/or dilator tube 50. The dilator tube 50 canthen be removed if it was used. The guide cannula 30 and/or therapy tool10 can be inserted through the stabilizer 40 with or without the guidepin 20 in place (that is the guide pin 20 can have been previouslyremoved or removed after the cannula 30 and/or tool 10 are insertedthrough the stabilizer 40). The tool 10 can deliver the therapy to thefacet joint J with the pin in position and extending through the pinbore 11 or the therapy to the facet joint can be applied after the pin20 is withdrawn.

In some embodiments, the order of use of the surgical tools can be asshown, in serial order with respect to the next set of noted figures:insert guide pin or k-wire 20 (FIG. 14A), insert dilator 50 over thepin/wire 20 (FIG. 14B), insert guide cannula 30 over dilator 50 (FIG.14E), then attach the hand grip 200 (FIG. 14F). As discussed above, thehand grip 200 can be (typically manually) rotated and pushedconcurrently to cut through adjacent tissue and place the distal end ofthe guide cannula 30 d at the target spinal facet treatment site J.Where a detachable hand grip 200 is used, the hand grip 200 can beremoved from the guide cannula 30 before the stabilizer 40 is attached.FIGS. 14C, 14E and 14G illustrate that the dilator 50 may also includevisual indicia 150 to allow a user to align/ascertain a depth thereofrelative to the guide pin visual indicia 120, for example. The guidepin/k-wire 20 can have a sharp distal end 20 d (FIGS. 14B, 14D). FIGS.14B and 14F illustrate that the dilator 50 may be visually transmissive.

The stop depth provided by the stabilizer 40 and/or stabilizer and guidecannula 30 combination may be adjustable. The clinician can decide anappropriate stop depth for the patient prior to placing one or more ofthe components in the patient.

The stabilizer 40 can also be placed on the skin S before or after theguide pin 20 is inserted at the treatment joint J. The stabilizer 40 mayhave a bottom surface 40 b that can releasably attach to skin of thepatient via adhesive or vacuum and the like and define an entry portalfor the procedure.

The entire tool 10 with the cable 13 can be sterile and single usedisposable.

The tool 10 can be configured to inhibit re-use. For example, the tool10 can have a reuse restriction circuit 180 as shown in FIGS. 8A-8C. Thereuse restriction circuit 180 can be in communication with the processorP or configured as part of the processor P itself or partly held on theprocessor P, the circuit C and/or partly in a separate circuit of thetool 10. The reuse restriction circuit 180 can include or be incommunication with one or more of a time-out circuit 180 t, an on and/oroff counter 180 c (to control a defined number of power-up, power downoperations and/or a number of successive power up and power downs, forexample), and/or a self-destruct circuit 180 d, to automatically disablethe device 10 from being able to operate to thereby restrict furtheruse. The self-destruct circuit 180 d can be configured to destroycertain components and/or functionality of the tool 10. The time-outcircuit 180 t can be configured to shut down or not power up after apower off and/or after a defined time from a defined trigger event. Theon/off counter 180 c can be configured to limit the number of on/offuses to less than 10, typically between 3-6, to allow for multiple leveltreatments and allow a user to power-off between levels.

The “trigger” event, can be based on one or a combination of a power-onor power off-event of the tool 10, electronic detection of a cauteryoutput at the end of the barrel of the tool, which may be determinedusing a temperature or other sensor on the end of the tool 10. Thetrigger event can be an active denuding time or an active cleansingtime, post cauterization, associated with motor rotation. The triggerevent can be based on a logic control of the processor P based on aplurality of pre-defined trigger event conditions to start the timeperiod such as (a) the tool being in a power-on state, (b) the presenceof a cautery temperature at the tool barrel, and (c) rotation of themotor. The defined time may be sufficient to allow for multiple spinalfacet levels to be treated for a respective patient using one tool 10,thus the time, when electronically sensed can be a cumulative time basedon active motor time, time from power on, a defined number of poweron/power off events, and the like. The defined time can be less thanabout 1 hour, typically between about 5 minutes to about 30 minutes,such as about 6 minutes, about 7 minutes, about 8 minutes, about 9minutes, about 10 minutes, about 11 minutes, about 12 minutes, about 13minutes, about 14 minutes, about 15 minutes, about 16 minutes, about 17minutes, about 18 minutes, about 19 minutes, about 20 minutes, about 25minutes and about 30 minutes, for example.

As shown in FIG. 8B, by way of example only, the tool circuit C caninclude a reuse restriction circuit 180 that includes a self destructcircuit 180 d that can carry out a self destruct mode based on one ormore defined parameters. In some embodiments, the one or more definedparameters includes a pre-defined time period, which may beautomatically timed using a clock or timer in communication with thereuse restriction circuit 180, typically in the processor P of thecircuit 10. The clock or timer can be configured to time a period ofallowable operation based on a power on a “trigger” event as describedabove and may be any of the time periods described above and/or triggerbased on defined trigger event conditions as discussed above.

As shown in FIG. 8B, the tool can generate an audio and/or visual output180 a to alert a user that the tool 10 has been self-destructed todestroy functionality of the tool 10. The output 180 may be a flashing(e.g., red) LED or other alert indicator. As shown by the circles withthe X, the self-destruct mode can be configured to disable or destroyoperational capability of the processor P and/or disconnect or destroyan electrical connection 10 c from one or more internal component suchas the battery B or the cautery input 80 i. The self-destruct mode canuse the battery B or the cautery generator 80 via input 80 i toelectrically destroy one or more internal components or electrically ormechanically disconnect power such as by cutting a wire or cord in apower cable or connector associated with same, for example after a timeout period and/or an attempt to power-on after the first authorized use,e.g., after 30 minutes from an initial power up.

In some embodiments, the self destruction circuit 180 d can beconfigured so that if the surgical tool 10 is disconnected (after afirst operation or “on” potentially for a defined time) from a physicalconnection, e.g., plug in, to the generator 80 or generator unit 80 h(FIG. 8C), the device 10 will self-destruct. In some embodiments,circuitry C in communication with (typically onboard) the device 10 canbe configured to sense that a power connection has been terminated andautomatically destroy functionality of one or more components. The tool10 cannot function to operably connect to a generator 80 or generatorhousing 80 h for a second power on, (e.g., a second surgical case).

FIGS. 7A and 7B also illustrate that the shaft 18 extends to therotating head 15 and can be configured with a fluted configuration 15 fto inhibit tissue clogging during denuding or tissue scraping. Thefluted configuration can have curvilinear longitudinally extendingrecesses 15 r.

The flutes 15 f can be straight or curvilinear. The flutes 15 f can bethin, e.g., between about 1 mm to about 5 mm. The flutes 15 f can extendlongitudinally over a small portion of the length of the shaft and/orbarrel 10 b, such as between about 3 mm to 1 inch, or over substantiallya length of the shaft and/or barrel 10 b sufficient to extend throughthe working cannula 30, e.g., a length between about 50 mm to about 200mm, including about 50 mm, about 75 mm, about 100 mm, about 150 mm andabout 200 mm. The head lateral dimension can be between about 3-15 mm(if a non-expandable configuration is used) and between about 3-25 mm ifan expandable version is used. In some embodiments, a maximal distalhead lateral dimension with the flutes 15 f can be between about 5-15 mmsuch as about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, andabout 15 mm.

As shown in FIGS. 7A and 7B, the head 15 can include a singlemedially-located linear conductive electro-cautery segment 15 e. Thelinear cautery element 15 e can be continuous and extend across theentire face of the head 15. As shown in FIG. 7B, the linear cauteryelement 15 e bisects the face of the tool head 15 and can separate twoopposing, non-conductive scraping members 15 s. The scraping members 15s can comprise PEAK or PEEK material, for example. The scraping members15 s may extend a distance of between about 0.5 mm to about 5 mm beyondthe cautery element 15 e. The scraping members 15 s can be used for bothdenuding, before cauterization and tissue cleansing (postcauterization), but typically a concurrent cautery and scraping actionis carried out, by rotating the head at a low rpm during cautery,typically between 10 and 100 rpm, as discussed above.

The head 15 can be a monolithic unitary member with the electrocautherysurface(s) 15 e and flutes 15 f. The entire shaft with the head can be amonolithic conductive member. The head 15 and/or shaft with the head canbe a suitable medical grade electrically conductive material such asstainless steel. The head 15 may comprise a discrete electrocauterymember 15 e that is of a different material than the fluted shaft 15 f.That is, as shown, the discrete electrocautery member 15 e can reside inor extend from a non-conductive (electrically insulating) shaft 18and/or barrel 10 b. The discrete electrocautery member 15 e can beconfigured to slidably, longitudinally extend and retract relative tothe adjacent non-conductive shaft or barrel or may be statically affixedto same.

It is contemplated that the spinal facet debridement procedure with thecombination debrider tool 10 can allow the spinal debridement procedureto be carried out by general surgeons, radiologist, pain medicine,physical medicine, orthopedic and neurosurgeons and/or allow moresurgeons to be able to competently carry out the procedure therebyproviding more global access to this treatment for patients with longerterm pain relief and obviating the need for follow-up treatments uponnerve renervation at the treated spinal facet joint(s).

Embodiments of the invention provide treatment methods that can becarried out at an outpatient clinic and/or as an outpatient procedure ata hospital or surgery center.

While the foregoing written description of the invention enables one ofordinary skill to make and use what is considered presently to be thebest mode thereof, those of ordinary skill will understand andappreciate the existence of variations, combinations, and equivalents ofthe specific embodiment, method, and examples herein. The inventionshould therefore not be limited by the above described embodiment,method, and examples, but by all embodiments and methods within thescope and spirit of the invention as claimed.

That which is claimed:
 1. A method of minimally invasively treating apatient for back pain, comprising: introducing a guide cannula into thepatient so that a distal end resides proximate a target spinal facetjoint; coupling the guide cannula to an external stabilizer before,during or after the introducing step; inserting a tool with a denudingand cauterization head through the guide cannula; connecting the tool toan electrosurgical generator with an RF source before, during or afterthe insertion; then denuding and cauterizing soft tissue at the targetspinal facet joint, serially or concurrently, using the denuding andcauterization head, wherein the denuding is carried out by rotating thedenuding and cauterization head of the tool to remove an end platereceptor region comprising a synovial capsule of the spinal facet jointthereby treating back pain, wherein the cauterizing is carried out usingthe electrosurgical generator configured with a power curve with amaximum output wattage of 60 Watts, a maximum current of 1000 mA, and amaximum voltage in a range of 180 V and 220 V with an ohmic range of0-3000 ohms; and suctioning fluid from the guide cannula during thecauterizing to exhaust heat generated from the cauterizing.
 2. Themethod of claim 1, wherein the power curve for the electrosurgicalgenerator has a maximum output wattage of 40 Watts, a maximum current of1000 mA, and a maximum voltage in a range of 180 V and 220 V with theohmic range of 0-3000 ohms.
 3. The method of claim 1, wherein thedenuding is carried out by rotating the head of the tool at a rotationalspeed of between 10 and 5000 rotations per minute.
 4. The method ofclaim 1, wherein the tool has an onboard electrical motor, wherein theelectrosurgical generator comprises a Field-Programmable Gate Array(FPGA) architecture for controlling output based on the power curve, andwherein the electrosurgical generator is held in a housing that alsoholds a power source for a motor that rotates the denuding andcauterization head.
 5. The method of claim 1, further comprising,concurrently pressing against and rotating a hand grip coupled to anexternal end portion of the guide cannula during or after the insertionto thereby place the denuding and cauterizing head in a desired positionat the target spinal facet joint.
 6. A surgical tool system for spinalfacet therapy comprising: a housing; a shaft held by the housing thatrotates at a low speed, wherein the shaft has a distal face with acautery element and one or more tissue scraping members; a connectorcoupled to the cautery element that electrically connects the cauteryelement to a cautery power source that is separate from the housing; anda circuit in the housing configured to carry out one or both of: (i)monitor wattage supplied by the cautery power source to inhibit orprevent operation if wattage is above 60 Watts; and/or (ii) destroy ordisengage one or more components of the circuit based on at least onedefined triggering event to inhibit re-use.
 7. The system of claim 6,wherein the cautery power source comprises an electrosurgical generatorhaving a defined operational power curve with a maximum wattage of 60Watts.
 8. The system of claim 7, wherein the electrosurgical generatorcomprises a Field-Programmable Gate Array (FPGA) architecture forcontrolling output based on the power curve.
 9. The system of claim 8,wherein the power curve has a maximum output wattage of 50 Watts, amaximum current of 1000 mA, and a maximum voltage in a range of 180V-220 V.
 10. The system of claim 8, wherein the power curve has amaximum output wattage of 40 Watts, a maximum current of 1000 mA, and amaximum voltage of 180 V 220 V.
 11. The system of claim 8, wherein theelectrosurgical generator is configured to supply cautery power to thecautery element while the shaft rotates or is stationary.
 12. The systemof claim 9, wherein the maximum voltage of the power curve has an ohmicrange of or within 0-3000 ohms.
 13. The system of claim 6, furthercomprising an electric motor coupled to the shaft that rotates theshaft.
 14. The system of claim 6, wherein the housing is a firsthousing, wherein the first housing holds a motor that rotates the shaft,and wherein the cautery power source comprises an electrosurgicalgenerator that is held in a second housing that also holds a shaftrotation power source that couples to the motor in the first housingthat rotates the shaft.
 15. The system of claim 14, wherein the firsthousing has a pistol grip configuration with a trigger that allows auser to turn on and off either or both rotation of the shaft and cauterypower to the cautery element.
 16. The system of claim 6, furthercomprising: a guide cannula having longitudinally spaced apart fluidports extending through a wall thereof, wherein the shaft is sized andconfigured to slidably extend down through the guide cannula; and anexternal stabilizer with a base and an upwardly extending tube above thebase, wherein the tube has an arm that releasably engages conduit thatextends to a vacuum source, and wherein the base is adapted to resideagainst skin of a patient while the tube is coupled to an outer wall ofthe guide cannula to thereby suction heat from the guide cannula andthrough the arm when the cautery element is cauterizing.
 17. The systemof claim 16, further comprising a hand grip member configured todetachably couple to the guide cannula to thereby allow a user toconcurrently rotate and push against the guide cannula to place theguide cannula in a desired position prior to inserting the shaft intothe guide cannula.
 18. The system of claim 17, wherein the hand gripmember has an open center channel extending therethrough with acircumferentially extending stop surface that releasably engages aproximal end of the guide cannula.
 19. The system of claim 6, whereinshaft is configured to rotate at between about 10 rpm to about 5000 rpmand to cause the one or more tissue scraping members to remove an endplate receptor region comprising a synovial capsule of a target spinalfacet joint.
 20. The system of claim 6, wherein the housing is a firsthousing that holds an electrical motor that rotates the shaft, whereinthe cautery power source is an electrosurgical generator that comprisesa Field-Programmable Gate Array (FPGA) architecture for controllingoutput based on a power curve, wherein the electrosurgical generator isheld in a second housing that also holds a power source for the motorheld by the first housing, and wherein the power curve has a maximumoutput wattage of 50 Watts, a maximum current of 1000 mA, and a maximumvoltage in a range of 180 V-220 V.
 21. The system of claim 20, whereinthe power curve has a maximum output wattage of 40 Watts, a maximumcurrent of 1000 mA, and a maximum voltage of 180 V-220 V with an ohmicrange of or within 0-3000 ohms.
 22. The system of claim 6, wherein thecautery element is a linear cautery element that extends straight acrossthe distal face of the shaft, and wherein the one or more tissuescraping members comprises first and second diametrically opposingtissue scraping members that are spaced apart with the linear cauteryelement therebetween.
 23. A medical external stabilizer with a base andan upwardly extending tube above the base, wherein the base comprises abottom surface with a perimeter with a width that is in a range of 2-6inches, wherein the tube has a smaller width than the base, wherein thetube has an outer wall with a vacuum port extending therethrough and anaxially extending open through channel, wherein the tube furthercomprises an arm that releasably engages conduit that extends to avacuum source, and wherein the bottom surface of the base is adapted toreside external of and against skin of a patient.
 24. The medicalexternal stabilizer of claim 23, wherein the arm extends substantiallyorthogonally outward from the axially extending open through channel ofthe tube.